Regulatory Affairs Specialist / Manager

Job Description:

Recruit123 is helping our client to hire a Regulatory Affairs Specialist/Manager. Our client is a growing pharmaceutical company, seeking a regulatory affairs professional to manage drug product registrations and ensure ongoing regulatory compliance across relevant markets.

Responsibilities:

• Prepare, compile, and submit CTD/ACTD-format regulatory dossiers for new drug registration, renewal, and variation applications with HSA and other regional health authorities
• Ensure pharmaceutical products remain compliant with applicable regulatory guidelines throughout the product lifecycle (GMP, pharmacovigilance, labelling requirements)
• Liaise with HSA and regional regulatory bodies on submission queries, product approvals, and post-market surveillance requirements
• Review drug labelling, packaging inserts, and promotional materials for regulatory compliance
• Monitor changes in pharmaceutical regulatory requirements across markets and assess impact on the product portfolio
• Collaborate with R&D, quality assurance, and commercial teams to support new drug launches and lifecycle management
• Support adverse event reporting and pharmacovigilance documentation where required
• Maintain accurate regulatory documentation, submission trackers, and product registration records
• (Manager level) Lead and mentor junior regulatory affairs staff; own regulatory strategy across a drug product portfolio; manage relationships with external regulatory consultants, CROs, and distributors across multiple markets

Requirements:

• Degree in Pharmacy, Life Sciences, Pharmaceutical Science, or related field
• Specialist: 2-5 years' relevant pharmaceutical regulatory affairs experience; Manager: 6+ years' relevant experience with prior team or portfolio management exposure
• Sound knowledge of HSA drug registration requirements and regional pharmaceutical regulatory frameworks (e.g. ASEAN ACTD, other applicable jurisdictions)
• Familiarity with CTD/eCTD dossier compilation and submission processes
• Strong attention to detail and ability to manage multiple drug submissions/deadlines concurrently
• Excellent written and verbal communication skills for liaising with health authorities and cross-functional teams
• Experience with electronic submission platforms (e.g. PRISM) and regulatory databases is a plus

Name: Lian Cher Chieh (Steffan)UEN: 202511044RLicense No.: 25C2810EARegistration No.: R1217705